ID

12807

Description

Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children; ODM derived from: https://clinicaltrials.gov/show/NCT01593488

Link

https://clinicaltrials.gov/show/NCT01593488

Keywords

  1. 12/21/15 12/21/15 -
Uploaded on

December 21, 2015

DOI

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License

Creative Commons BY 4.0

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Eligibility Acute Lymphoblastic Leukemia NCT01593488

Eligibility Acute Lymphoblastic Leukemia NCT01593488

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of acute lymphoblastic leukemia (all)
Description

all

Data type

boolean

Alias
UMLS CUI [1]
C0023449
central nervous system involvement with malignant cells present in cerebrospinal fluid
Description

cns leukemia

Data type

boolean

Alias
UMLS CUI [1]
C1332884
cns involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence
Description

recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0277556
cns involvement may be an isolated lesion or present with other sites of disease
Description

cns involvement may be an isolated lesion or present with other sites of disease

Data type

boolean

Alias
UMLS CUI [1]
C0346429
UMLS CUI [2]
C0023449
ecog performance status 0-2
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 8 weeks
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
absence of severe organ dysfunction
Description

organ dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0349410
informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
eligibility for aieop studies of first recurrence of all,and receiving therapy in a center participating in the aieop studies
Description

eligibility for aieop studies

Data type

boolean

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C0173324
concurrent treatment with experimental therapies
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
severe neurologic toxicities from previous chemotherapy
Description

neurologic toxicities

Data type

boolean

Alias
UMLS CUI [1]
C3160947
severe coagulopathy at time of recurrence
Description

coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
sepsis
Description

sepsis

Data type

boolean

Alias
UMLS CUI [1]
C0243026
intrathecal therapy within 1 week of planned study therapy
Description

intrathecal therapy

Data type

boolean

Alias
UMLS CUI [1]
C1831734
total body or head and spine radiation within 8 weeks of enrolment
Description

radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0205918
bone marrow transplant within 8 weeks of start of study therapy.
Description

bone marrow transplant

Data type

boolean

Alias
UMLS CUI [1]
C0005961

Similar models

Eligibility Acute Lymphoblastic Leukemia NCT01593488

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
all
Item
diagnosis of acute lymphoblastic leukemia (all)
boolean
C0023449 (UMLS CUI [1])
cns leukemia
Item
central nervous system involvement with malignant cells present in cerebrospinal fluid
boolean
C1332884 (UMLS CUI [1])
recurrent disease
Item
cns involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence
boolean
C0277556 (UMLS CUI [1])
cns involvement may be an isolated lesion or present with other sites of disease
Item
cns involvement may be an isolated lesion or present with other sites of disease
boolean
C0346429 (UMLS CUI [1])
C0023449 (UMLS CUI [2])
ecog performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least 8 weeks
boolean
C0023671 (UMLS CUI [1])
organ dysfunction
Item
absence of severe organ dysfunction
boolean
C0349410 (UMLS CUI [1])
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
eligibility for aieop studies
Item
eligibility for aieop studies of first recurrence of all,and receiving therapy in a center participating in the aieop studies
boolean
C0013893 (UMLS CUI [1,1])
C0173324 (UMLS CUI [1,2])
study subject participation status
Item
concurrent treatment with experimental therapies
boolean
C2348568 (UMLS CUI [1])
neurologic toxicities
Item
severe neurologic toxicities from previous chemotherapy
boolean
C3160947 (UMLS CUI [1])
coagulopathy
Item
severe coagulopathy at time of recurrence
boolean
C0005779 (UMLS CUI [1])
sepsis
Item
sepsis
boolean
C0243026 (UMLS CUI [1])
intrathecal therapy
Item
intrathecal therapy within 1 week of planned study therapy
boolean
C1831734 (UMLS CUI [1])
radiation therapy
Item
total body or head and spine radiation within 8 weeks of enrolment
boolean
C0205918 (UMLS CUI [1])
bone marrow transplant
Item
bone marrow transplant within 8 weeks of start of study therapy.
boolean
C0005961 (UMLS CUI [1])

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